Laser Therapy Following Radiotherapy for Gynecological Cancer

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliKuajiri

Wadhamini

National and Kapodistrian University of Athens

JARIBIO LA KLINIKI: NCT03714581

BioSeek: NCT03714581

Maneno muhimu

saratani

Kikemikali

Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.

Tarehe

Imethibitishwa Mwisho:	06/30/2019
Iliyowasilishwa Kwanza:	10/13/2018
Uandikishaji uliokadiriwa Uliwasilishwa:	10/17/2018
Iliyotumwa Kwanza:	10/21/2018
Sasisho la Mwisho Liliwasilishwa:	07/27/2019
Sasisho la Mwisho Lilichapishwa:	07/29/2019
Tarehe halisi ya kuanza kwa masomo:	11/14/2018
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	05/31/2021
Tarehe ya Kukamilisha Utafiti:	05/31/2021

Hali au ugonjwa

Pelvic Radiotherapy

Gynecological Cancer

Dyspareunia

Vaginal Dryness

Uingiliaji / matibabu

Device: Microablative Fractional CO2 Laser Therapy

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: Laser Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)
Placebo Comparator: Placebo Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.

Vigezo vya Kustahiki

Jinsia Inastahiki Kujifunza

Female

Hupokea Wajitolea wa Afya

Ndio

Vigezo

Inclusion Criteria:

- History of gynecological cancer treated with pelvic radiotherapy

- last radiotherapy >1 year

- women sexually active or willing to resume sexual activity

- symptoms of dyspareunia, vaginal dryness, itching/burning and vaginal bleeding related to sexual intercourse

Exclusion Criteria:

- Relapse of gynecological cancer

- prolapse stage >1

- active genital infection (i.e herpes, vaginitis)

- underlying pathologies that could interfere with patients compliance to the protocol (i.e any psychiatric condition)

Matokeo

Hatua za Matokeo ya Msingi

1. 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness [Change from baseline at 1 month post-treatment]

It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness

Hatua za Matokeo ya Sekondari

1. 3 days voiding diary [Change from baseline at 1 month post-treatment]

Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake

2. Day-to Day Impact of vaginal aging questionnaire (DIVA) [Change from baseline at 1 month post-treatment]

It includes 4 domains: activities of daily living (5 items), sexual functioning (5 items), emotional well-being (4 items), self-concept and body image (5-items). Each item of each domain could receive values from 0 to 4. Mean scores are calculated on each of the domain scales. Higher scores indicate greater symptom impact

3. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) cervical cancer module (CX24) [Change from baseline Quality of Life questionnaire (QLQ) cervical cancer module (CX24) at 1-month post-treatment]

It includes 4 functional scales (body image, sexual activity, sexual enjoyment, sexual/vaginal functioning) with 9 items and 5 symptoms scales (symptoms experience, lymphedema, peripheral neuropathy, menopausal symptoms and sexual worry) with 15 items. Each item range from 1 to 4. Higher scores in sexual activity and sexual enjoyment indicate better functioning, while higher scores in all other domains indicate higher impact of cervical cancer

4. Patients Global Impression of Improvement [At 1-month post-treatment]

It is a single item questionnaire assessing the impression of participants following the intervention

5. International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) [Change from baseline International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) at 1-month post-treatment]

It is a 12-items questionnaire evaluating nocturia, urgency, bladder pain, frequency, hesitancy, straining, intermittency, urinary incontinence (urge, stress and unexplained), frequency of urinary incontinence and nocturnal enuresis. Filling, voiding and incontinence symptoms subscales range from 0 to 15, 0 to 12 and 0 to 20, respectively.

6. King's Health Questionnaire (KHQ) [Change from baseline King's Health Questionnaire at 1-month post-treatment]

It has 3 sections: 1) general health and overall health related to urinary symptoms with 2 questions, 2) incontinence impact, role limitations, physical limitations, social limitations, personal limitations, emotions, sleep and energy, and severity coping measures with 19 questions and 3) bother or impact of urinary symptoms with 11 questions. Scores of each domain of the 2 sections range from 0 to 100. Scores of the third section range from 0 to 3. Higher scores indicate higher impact of urinary incontinence.

7. Female Sexual Function Index [Change from baseline Female Sexual Function Index at 1-month post-treatment]

It includes 6 domains assessing sexual functioning (desire, arousal, orgasm, lubrication, satisfaction and pain). Total score is calculated by summing scores of the 5 domains multiplied by certain factors with a minimum value of 2 and maximum 36

8. Vaginal Maturation Value [Change from baseline Vaginal Maturation Value at 1-month post-treatment]

It is calculated by defining the percentage of superficial, intermediate and parabasal epithelial cells on the vaginal pap smear, following the formula (1x%superficial)+(0.5x%intermediate)+(0x%parabasal). It may receive values from 0 to 100%.It is considered to be an indicator of the estrogenic stimulation, whereas values of 0-49%, 50-64% and 65-100% indicate absent/low, moderate and high estrogenic effect on the vaginal epithelium, respectively.

9. Vaginal Health Index Score [Change from baseline Vaginal Health Index Score at 1-month post-treatment]

It evaluates vaginal elasticity, fluid volume, ph of vaginal fluid, epithelial integrity and moisture. Each one of these may receive scores from 1 to 5. Total score is calculated by summing the 5 scores ranging from 5 to 25. Higher scores indicate better vaginal status.

10. Partner Performance Questionnaire [Change from baseline Partner Performance Questionnaire at 1-month post-treatment]

It evaluates aspects of sexual satisfaction of cancer survivors partners